Trial information
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Zenapax (Daclizumab)
Status: Completed
Protocol number: PA16215
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: An open-label study to determine whether Zenapax impairs the ability to elicit a primary immune response in children who have received a kidney transplant
Brief summary: This study will assess whether Zenapax impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
82.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: daclizumab[Zenapax]
Primary outcome: 1. Efficacy: Evaluation of tetanus and keyhole limpet hemocyanin (KLH) antibodies; detection of cellular responses to tetanus and KLH antibodies
Key secondary outcomes: 1. Safety: Weight, vital signs, and adverse events
Inclusion criteria:
- primary renal transplant recipients between 2 and 19 years of age;
- receiving or have received Zenapax in the previous 4-18 months;
- receiving or have received Zenapax <24 hours pretransplant and additional courses twice a week;
- single organ recipients (kidney only);
- previous vaccination with tetanus toxoid (TT) prior to transplant;
- receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid).
Exclusion criteria:
- received intravenous gamma globulin or a TT vaccination since transplant;
- experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations;
- received any vaccine within 30 days of receiving study vaccinations;
- received plasmapheresis treatment or growth hormone treatment since transplant.
Gender: Males or Females
Age limits: Min: 2 Years Max: 19 Years
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Los Angeles, CA
- Indianapolis , IN
- Kansas City, MO
- Portland, OR
